Z-2301-2014 Class II Terminated

Recalled by Zimmer, Inc. — Warsaw, IN

FDA device recall Z-2301-2014 was initiated by Zimmer, Inc. on Jun 10, 2013 and is designated Class II. Reason for recall: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken… The recall status is terminated (terminated Sep 11, 2014). Affected quantity: 70,986 distribution events.

Recall Details

Product Type
Devices
Report Date
Aug 27, 2014
Initiation Date
Jun 10, 2013
Termination Date
Sep 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70,986 distribution events

Product Description

Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP

Reason for Recall

Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

Distribution Pattern

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.

Code Information

Item Numbers: 42517600410 42517600510 42517600610 42517600710 42517600810 42517600910 Lot Numbers: 62342526 62423918 62423919 62423920 62427414 62482212 62563745 62612225 62656072 62740698 62342527 62405895 62430401 62504179 62511925 62563784 62638665 62695870 62343066 62406967 62432146 62515486 62564324 62691390 62717335 62351291 62374838 62415307 62430397 62518138 62622527 62696875 62357867 62374796 62427836 62441229 62511924 62565948 62563908 62590523 62695295 62361315 62376662 62420192 62434748 62518137 62540059 62563778 62627131 62698733

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2301-2014
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.